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FDA 510(k)

COOLTOUCH MODELS LC215 AND COOLLIPO

K-Number: K080163 · 2008-04-10

ApplicantNew Star Lasers, Inc.
Decision Date2008-04-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLTOUCH MODELS LC215 AND COOLLIPO is the device name listed in this FDA 510(k) record. The listed applicant is New Star Lasers, Inc.. It received FDA 510(k) clearance on 2008-04-10 under 510(k) number K080163. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOLTOUCH MODELS LC215 AND COOLLIPO?

COOLTOUCH MODELS LC215 AND COOLLIPO is a medical device that received FDA 510(k) clearance on 2008-04-10. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K080163.

When did COOLTOUCH MODELS LC215 AND COOLLIPO receive FDA 510(k) clearance?

COOLTOUCH MODELS LC215 AND COOLLIPO received FDA 510(k) clearance on 2008-04-10, under 510(k) number K080163.

Who is the listed applicant for COOLTOUCH MODELS LC215 AND COOLLIPO?

The FDA 510(k) record lists New Star Lasers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOLTOUCH MODELS LC215 AND COOLLIPO?

The FDA product code for COOLTOUCH MODELS LC215 AND COOLLIPO is GEX. This falls under the Gastroenterology category.

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Other records listing New Star Lasers, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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